Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study (NCT03289026) | Clinical Trial Compass
CompletedPhase 4
Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
China770 participantsStarted 2017-09-01
Plain-language summary
This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia.
* acute episode; inpatients
* Age from 18-65 years old (inclusion), male or female
* PANSS total score at least 70
* scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score
* Written informed consent
Exclusion Criteria:
* other serious diseases;
* Pregnant or breast feeding women or planning a pregnancy
* Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect;
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Allergy to Aripiprazole
* History of alcohol or drug abuse or dependence in the past 1-year before screening
* mental retardation; bipolar disorder; major depressive disorder;
* Currently using one kind of antipsychotic drug at a dose that exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using two kinds of antipsychotic drugs, at least one of which reaches or exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using three kinds of antipsychotic drugs or more;
* Refractory schizophrenia patient…
What they're measuring
1
PANSS (positive and negative symptoms scale) total score